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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Brazil's Anvisa Addressing Drug Approval Priorities

Posted 05 October 2012 | By Louise ZornozaRegLink

Brazil's national regulatory authority, Anvisa, announced on 4 October a number of steps it has implemented to address the priority public health needs of the country, part of a multi-year reorganization aimed at better addressing the health and economic development needs of the country and its population.

One of the measures it has implemented is the establishment of an expedited review and approval procedure for medicines deemed to be priority treatments for use by the national health service (SUS). Drugs eligible for the &nbsp;expedited procedure include generics as well as innovative new drugs.&nbsp;

Another measure is its review of its regulatory framework. It said it has made a number of changes where necessary, including simplifying the registration process and entering into information exchange agreements on manufacturing site inspections with counterpart regulatory agencies in a number of countries, such as Argentina, Australia, Canada, France, the UK and the US.&nbsp;

The agency is also in the process of implementing an electronic application filing process, due to launch &nbsp;later this year, which will further speed up product reviews.

Anvisa also provided a review of its achievements over the last three years. Between 2009 and 2012, it said, 214 applications for registration of new molecules were filed with Anvisa. Of these, 87% have been reviewed by the agency and 62% (133 requests) have had a final determination (acceptance, rejection or termination of proceedings on request) issued by the agency. Twenty-five percent (54 requests) are currently under review, while only 13% (27 applications ) are awaiting the initiation of review. &nbsp;The oldest application without response from Anvisa was filed in March of this year.